Medical Cannabis is Now Legal in Ukraine

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Today, August 16, 2024 marks a remarkable moment in Ukrainian history - the new medical cannabis regulatory framework officially comes into force.

Under the new regulatory framework cannabis is now excluded from the list of prohibited substances enabling cannabis research and medical use. Presently, manufacturers of Cannabis Active Pharmaceutical Ingredients (API) and consumer-level medical cannabis products can initiate the product registration process, which is now shortened to 30 days. In accordance with the new regulatory framework, manufacturers of cannabis APIs and consumer-level medical cannabis products must comply with Good Agricultural and Collection Practices (GACP) and European Union Good Manufacturing Practices (EU-GMP) regulatory requirements. Enforcement of the medical cannabis regulatory framework would be performed by The State Service of Ukraine on Medicines and Drugs Control.

It is probable, that in the fall of 2024, Ukrainian patients could get access to safe, traceable and quality-controlled medical cannabis products.

Presently education of medical doctors who would prescribe medical cannabis is underway. To reduce the negative impact of medical cannabis legalization in Ukrainian communities regulatory authorities may need to initiate educational campaigns that would facilitate harm reduction and promote health awareness when it comes to legal medical cannabis use. Hence, enabling responsible and informed access to medical cannabis.

“If you are under 25 or younger, consumption of THC especially in high levels affects the prefrontal lobe development which is the part of the brain that does problem-solving. Just because it’s legal doesn’t mean it’s safe.” - says Alex Abellan the founder of National Access Cannabis, Canada’s first medical cannabis distribution network, highlighting the paramount importance of the safe distribution of medical cannabis in Ukraine.

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Medical Cannabis Regulatory Framework Highlights from The Ministry of Health of Ukraine

The Circulation of Cannabis for Medical Purposes is Allowed

Cannabis resin, extracts and tinctures are excluded from the list of particularly hazardous substances. THC content in dried medical cannabis material/biomass must be equal or greater than 0.3%.

Cultivation of Medical Cannabis

Licensing conditions have been developed and will soon be validated by the Cabinet of Ministers of Ukraine. The entire chain of medical cannabis circulation will be subject to licensing control - from import or cultivation to dispensing of medical cannabis to patients in a pharmacy.

The Procedure for Purchasing Plant Seeds

Seeds must have a quality certificate and should be registered with the State Register of Plant Varieties suitable for distribution in Ukraine.

Testing for THC Content

Laboratory tests for the THC content will be performed exclusively in state laboratories, and plant samples will be taken with the participation of the National Police.

Electronic Traceability System

Each medical cannabis procedure/process must be documented and registered in the electronic system within the next day after it is completed.

To comply with regulatory requirements, Ukrainian Medical Cannabis manufacturers should report through the system information on the production of medical cannabis seeds, sowing, cloning, planting of plants and planting material, sending samples for laboratory testing, harvesting of plants, transportation, purchase transactions, manufacturing of medicines, destruction of waste, dispensing in a pharmacy, etc.

In total, more than 30 types of processes/procedures will be recorded for more than 10 accounting objects. The system will be launched in the fall of 2024.

Import of Herbal Substances

To import raw materials into Ukraine, a licensed importer must obtain a permit from the State Service of Ukraine on Medicines and Drugs Control and should not exceed the quotas established by the state. The substance will be registered as an API.

Medicines Based on Medical Cannabis

Medicinal cannabis products will be manufactured in a pharmacy and prescribed in the form of a prescription to patients if there are reasonable grounds that conventional medicines have no therapeutic effect or cause adverse reactions that are poorly tolerated by the patient.

Such medicines will be available in Ukraine only on the basis of an electronic prescription, which will specify the pharmaceutical form and dosage, as well as the names of the active ingredients in the medicines.

It is expected that medical cannabis medicines will be available to patients in the form of oral drops, hard capsules, and dental pastes.

Import of Medicines for Personal Use

People entering or leaving Ukraine or transiting through its territory are allowed by law to carry medical cannabis-based medicines for their own use in an amount not exceeding the amount specified in a doctor's prescription.

Medical Cannabis is Now Legal in Ukraine

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